26/03/2026 UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG Soligenix received orphan drug designation from the European Commission for SGX945 for the treatment of Behçet's Disease UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG ( Ref ) UCB announced that the European Medicines Agency’s CHMP had issued a positive opinion to expand the use of  ZILBRYSQ® (zilucoplan; C5 inhibitor), with a new pre-filled pen device as an add

23/03/2026 Gilead Sciences to acquire Ouro Medicines to advance first in class T cell engager program for autoimmune diseases Apogee Therapeutics announced Phase 2 results of zumilokibart in Moderate-to-Severe AD Galapagos and Gilead in advanced discussions to collaborate on advancing first in class T cell engager program for autoimmune diseases Kali Therapeutics announced a worldwide exclusive license agreement with Sanofi for KT501 for autoimmune diseases Gilead Sciences to

19/03/2026 GSK announced FDA approval of linerixibat for adult patients with PBC GSK announced FDA approval of linerixibat for adult patients with PBC ( Ref ) GSK announced that the US FDA had approved Lynavoy (linerixibat; an IBAT inhibitor) for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC) The approval was based on data from the global Phase 3, GLISTEN/ NCT04950127 trial The trial met both primary and key secondary endpoints,

18/03/2026 J&J announced FDA approval for icotrokinra for adult and pediatric patients with moderate to severe plaque psoriasis J&J announced FDA approval for icotrokinra for adult and pediatric patients with moderate to severe plaque psoriasis ( Ref ) Johnson & Johnson announced that the US FDA had approved ICOTYDE™ (icotrokinra; IL-23 receptor antagonist) for the treatment of adults and pediatric patients aged 12 years and older who weighed at least 40 kg with moderate to s

16/03/2026 Spyre Therapeutics announced results from the Phase 2 rheumatoid arthritis sub-study InnoCare Pharma announced that ICP-538 had been approved for clinical trials in China and had completed dosing of the first subject Lilly announced Phase 3 results of lebrikizumab in pediatric patients with moderate-to-severe AD Sun Pharma announced US FDA had accepted for review the sBLA for tildrakizumab for the treatment of adults with active PsA Spyre Therapeutics announced res

11/03/2026 UCB announced Phase 3 results of  bimekizumab versus Risankizumab in a head-to-head study in PsA UCB announced Phase 3 results of  bimekizumab versus Risankizumab in a head-to-head study in PsA ( Ref ) UCB announced positive topline results from its Phase 3 BE BOLD/ NCT06624228 head-to-head study, which evaluated BIMZELX®▼(bimekizumab; a selective inhibitor of IL-17A and IL-17F) versus SKYRIZI® (risankizumab; a selective inhibitor of IL-23) for the treatment of adu

10/03/2026 Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD ( Ref ) Redx Pharma announced that the US FDA had granted fast track designation to RXC008 (a GI-restricted pan-ROCK inhibitor) for the treatment of patients with fibrostenotic crohn’s disease (CD) Lisa Anson, CEO, Redx Pharma: “ Redx have been working closely with the FDA and the STAR consortium to define the regulatory

09/03/2026 Pfizer announced Phase 2 results of tilrekimig in AD Vertex announced Phase 3 results of Povetacicept in IgA Nephropathy Pfizer announced Phase 2 results of tilrekimig in AD ( Ref ) Pfizer announced positive topline results from its Phase 2 study that evaluated tilrekimig (PF-07275315; trispecific antibody targets Il-4, IL-13 and TSLP) for the treatment of adult patients with moderate to severe atopic dermatitis (AD) The study met its primary endpoint, demonstratin

06/03/2026 The US FDA approved deucravacitinib for the treatment of patients with active PsA Aisa Pharma announced the results from its Phase 2 trial of AISA-021 in patients with SSc RP The US FDA approved deucravacitinib for the treatment of patients with active PsA ( Ref ) BMS announced that the US FDA had approved Sotyktu® (deucravacitinib; TYK2 inhibitor) for the treatment of adult patients with active psoriatic arthritis (PsA) The approval was based on positive results f

03/03/2026 UCB and Antengene entered into a global license agreement for ATG-201 targeting B cell-related autoimmune diseases Johnson & Johnson received US FDA fast track designation for nipocalimab in SLE Priovant’s brepocitinib received US FDA acceptance and priority review for patients with dermatomyositis COUR Pharma announced Phase 2a results of CNP-104 in PBC Kyowa Kirin announced the discontinuation of rocatinlimab clinical trials UCB and Antengene entered into a globa

02/03/2026 Lynk Pharmaceuticals announced positive Phase 3 data for zemprocitinib in moderate-to-severe atopic dermatitis Abbive announced topline results form a Phase 3 study that evaluated resankizumab subcutaneous induction in patients with CD Roche announced positive results from a Phase 3 study that evaluated fenebrutinib in patients with RMS Sanofi's rilzabrutinib earned orphan drug designation in Japan for IgG4-related disease Lynk Pharmaceuticals announced positive Ph

24/02/2026 Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis J&J submitted sBLA to the US FDA for approval of IMAAVY® for warm autoimmune hemolytic anemia Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis ( Ref ) Abcuro announced topline results from its Phase 2/3 MUSCLE/ NCT05721573 study, which evaluated ulviprubart (ABC008; anti-KLRG1) for the tre

19/02/2026 AstraZeneca’s Saphnero was approved in Japan for patients with Systemic Lupus Erythematosus AstraZeneca’s Saphnero was approved in Japan for patients with Systemic Lupus Erythematosus ( Ref ) AstraZeneca announced that Japan had approved Saphnero (aniflorumab; anti-IFN1R) subcutaneous injection 120 mg autoinjector for the treatment of patients with Systemic Lupus Erythematosus (SLE) This approval by the Ministry of Health, Labour and Welfare was based on the result

16/02/2026 Roche announced positive Phase 3 results for Gazyva/Gazyvaro in primary membranous nephropathy Roche announced positive Phase 3 results for Gazyva/Gazyvaro in primary membranous nephropathy ( Ref ) Roche announced positive results from the Phase 3 MAJESTY/ NCT04629248 study which evaluated the efficacy and safety of Gazyva/Gazyvaro (obinutuzumab; anti-CD20) in patients with primary membranous nephropathy The study met its primary endpoint of complete remission at t

13/02/2026 Novartis announced Phase 3 data in adult patients with IgA nephropathy Novartis announced Phase 3 data in adult patients with IgA nephropathy ( Ref ) Novartis announced final results from its Phase 3 ALIGN/ NCT04573478 study which evaluated Vanrafia (atrasentan; an ETA receptor antagonist) in adult patients with IgA nephropathy (IgAN) The study demonstrated a slowing of kidney function decline in adult patients with IgAN The ALIGN study showed a difference of 2.39

12/02/2026 The European Commission approved inebilizumab for the treatment of generalized myasthenia gravis The European Commission approved inebilizumab for the treatment of generalized myasthenia gravis ( Ref ) The European Commission approved Amgen’s Uplizna®(inebilizumab; anti-CD19 mAb) as an add-on treatment to standard therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (M

10/02/2026 US FDA accepted NDA and granted priority review for Takeda’s oveporexton as a potential first-in-class therapy for Narcolepsy Type 1 Evommune reported positive top-line data from Phase 2a POC trial of EVO301 in moderate-to-severe atopic dermatitis Kincell Bio partnered with Regcell to advance Treg cell therapies into clinical trials for autoimmune diseases US FDA accepted NDA and granted priority review for Takeda’s oveporexton as a potential first-in-class therapy